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โ† Trials
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Pancreatic Neuroendocrine Tumour - Optimal Surgical Debulking or Not

RecruitingNAAges 18 Years - anyAllUppsala University
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In plain words

What the trial is, and whether it could suit you

Pancreatic neuroendocrine tumours (pan-NETs) are neoplasms arising from the endocrine cells of the pancreas. Although pan-NET are quite rare, the incidence is on the rise and together with other abdominal neuroendocrine tumours an approximate incidence in Sweden would be 850 patients per year extrapolating from Norwegian data. Pan-NET are divided into symptomatic hormone producing tumours (such as insulinomas/glucagonomas/VIPomas) or non-functioning tumours that often are asymptomatic. As early symptoms often are lacking in non-functioning-pan-NET, many patients present with distant metastases and are thus beyond a curative surgical approach at the time of diagnosis. Metastatic non-functioning pan-NETs present a significant challenge and the optimal management remains a subject of debate. This is a prospective, two armed, parallel, randomised, controlled, international multi-centre stud

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Pan- NET, ENETS/AJCC stage 4 determined by CT or PET/CT * Primary tumour or metastases confirmed as Pancreatic NET GI-WHO grade 1-2 pan-NET by histology or cytology * Age โ‰ฅ 18 years * Written informed consent obtained Exclusion Criteria: * Subject not fit for surgery due to comorbidity or advanced age (reason to be specified) * Risk of surgery deemed too high by MDT or Surgeon (reason to be specified) * Previous surgery for pan-NET. * Hormonal symptoms caused by a functional pan-NET, not controllable by medical therapy, indicating debulking surgery. * Previously included in the current study. * Pregnancy * The study subject does not fit into either STRATA: a) STRATUM 1: Less than 70% of the total tumour volume can be debulked, b) STRATUM 2: no FDG-PET avid disease is observed OR all (100%) FDG-PET avid tumour is not resectable. * Other reason in the opinion of the Principal Investigator (reason to be specified).
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What it tests

  • Debulking surgery
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Where

4 sites
Sahlgrenska University Hospital
Gothenburg, Sweden
Skรฅne University Hospital
Lund, Sweden
Karolinska University Hospital
Stockholm, Sweden
Uppsala University Hospital
Uppsala, Sweden
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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